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Type: Peer Reviewed Publications

Peer Review | ctDNA Clearance as an Early Indicator of Improved Clinical Outcomes in Advanced NSCLC Treated with TKI: Findings from an Aggregate Analysis of Eight Clinical Trials

Peer Review | An Analysis of 20 Independently Performed Assays to Measure Homologous Recombination Deficiency (HRD) in Ovarian Cancer: Findings from the Friends’ HRD Harmonization Project

Peer Review | Sponsor Perspectives on the Impact of the COVID-19 Pandemic on Interventional Cancer Clinical Trial Protocols and Data Quality

Peer Review | Bridging research and practice: enhancing regulatory decisions with pragmatic clinical trials in oncology

Peer Review | Evaluation of Real-World Tumor Response Derived From Electronic Health Record Data Sources: A Feasibility Analysis in Patients With Metastatic Non–Small Cell Lung Cancer Treated With Chemotherapy

Peer Review | An evaluation of novel oncology approvals with a PMR/C for assessing data in racial and ethnic populations underrepresented in premarket clinical trials

Peer Review | Advancing Evidence Generation for Circulating Tumor DNA: Lessons Learned from A Multi-Assay Study of Baseline Circulating Tumor DNA Levels across Cancer Types and Stages

Peer Review | Accelerating the development of genetically engineered cellular therapies: a framework for extrapolating data across related products

Peer Review | An Analysis of Dosing-Related Postmarketing Requirements for Novel Oncology Drugs Approved by the U.S. Food and Drug Administration, 2012–2022

Peer Review | A National Assessment of Diagnostic Test Use for Patients with Advanced NSCLC and Factors Influencing Physician Decision-Making

Background Diagnostic tests, including US Food and Drug Administration (FDA)-approved tests and laboratory-developed tests, are frequently used to guide care for patients with cancer, and, recently, have been the subject of several policy discussions and insurance coverage determinations. As the use of diagnostic testing has evolved, stakeholders have raised questions about the lack of standardized…